MAUDE Adverse Event Report: DEFIBTECH, L.L.C. LIFELINE; AUTOMATED CHEST COMPRESSOR

Model Number RMU-1000

Device Problem Mechanical Problem (1384)

Patient Problem Cardiac Arrest (1762)

Event Date 12/23/2023

Event Type  malfunction  

Manufacturer Narrative

Although requested, the device associated with this complaint has not been returned and the cause of the complaint is not known.Should additional information become available a follow-up mdr shall be submitted.

Event Description

A customer reported that while running a code, the rmu-1000 ceased performing compressions, followed by the warning and maintenance lights going off and beeping.They attempted to troubleshoot on scene but resorted to manual compressions.The patient was not resuscitated.

• Brand Name: LIFELINE
• Type of Device: AUTOMATED CHEST COMPRESSOR
• Manufacturer (Section D): DEFIBTECH, L.L.C.; 741 boston post rd.; suite 201; guilford CT 06437
• Manufacturer (Section G): DEFIBTECH, L.L.C.; 14 commercial st.; branford CT
• Manufacturer Contact: ian white ; 741 boston post road; suite 201; guilford, CT 06437 ; 2034536654
• MDR Report Key: 18542648
• MDR Text Key: 333234814
• Report Number: 3003521780-2023-00316
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 10815098020536
• UDI-Public: 10815098020536
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: RMU-1000
• Date Manufacturer Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 113 KG